SOMNOFIT— 510(k) K060795

Substantially Equivalent

Strategic Counsel Sarl

FDA 510(k) clearance K060795 for SOMNOFIT, Substantially Equivalent on 2006-12-18. Applicant: Strategic Counsel Sarl.

Clearance details

Applicant: Strategic Counsel Sarl
Product code: Code LRK
Advisory panel: Dental
Date received: 2006-03-23
Decision date: 2006-12-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.